الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

a-s medication solutions - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - asthma symbicort rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration). chronic obstructive pulmonary disease (copd) symbicort 200/6 is indicated for the symptomatic treatment of moderate to severe copd (fev1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. symbicort is not indicated for the initiation of bronchodilator therapy in copd.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

remedyrepack inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: - budesonide and formoterol fumarate dihydrate inhalation aerosol is not indicated for the relief of acute bronchospasm. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)]. formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations) .  in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations labor or delivery there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species.  however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above).  in a pre- and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother`s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child from formoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labeled 3 h  formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects.

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - formoterol fumarate dihydrate -

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

orient europharma (m) sdn bhd - beclomethasone dipropionate; formoterol fumarate dihydrate; glycopyrronium bromide -

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema  formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ].  formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1) ]. formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations). in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations labor or delivery there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.   data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species. however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). in a pre-and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother`s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child fromformoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labeled 3h-formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions   (5.2)] . formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a long-acting beta2 -adrenergic agonists (laba), including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation